New Method: Clinical EndoscopyHuman application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction: multicenter pilot study
Section snippets
Patients
From July 2003 to August 2006, patients who agreed to the insertion of a MSCPM were prospectively enrolled from 4 endoscopy centers; 3 experienced gastroenterologists performed the ERCP. Inclusion criteria were as follows: obstructive jaundice that resulted from a malignant biliary stricture and inoperability on the basis of the patient's general condition or progressive tumor extension. The protocol was approved by the ethics committees of the participating institutions, and a written informed
Patient characteristics
The mean age of the patients was 74 years (range 50-93 years). The mean follow-up period was 329 days (range 68-811 days). The causes of biliary obstruction were pancreatic cancer in 9 patients (43%), bile-duct cancer in 8 (38%), and ampulla cancer in 4 (19%). A pathologic confirmation of malignancy was obtained for 12 of the 21 patients (57%) (Table 1).
Stent occlusion and complications after MSCPM insertion
MSCPM occlusion was observed in 9 patients (43%); the causes of occlusion were bile sludge or clog in 4, tumor overgrowth in 3, and tumor
Discussion
Paclitaxel has been used clinically in systemic chemotherapy and coronary stents for many years, but there are few clinical studies, either experimental and preliminary, on the long-term effect of paclitaxel on the bile duct via a paclitaxel-integrated biliary stent.11, 12, 13 In our porcine animal model,4 we documented that an MSCPM was safe to the normal bile duct and suggested that further clinical trials with long-term follow-up examination in human beings were needed. In this clinical
References (24)
- et al.
Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction
Lancet
(1994) - et al.
The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane
Gastrointest Endosc
(2005) - et al.
Polyurethane-covered metal stent for management of distal malignant biliary obstruction
Gastrointest Endosc
(2002) - et al.
Effects of a holmium-166 incorporated covered stent placement in normal canine common bile ducts
J Vasc Interv Radiol
(2005) - et al.
New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction
J Vasc Interv Radiol
(2002) - et al.
Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction
Gastrointest Endosc
(2005) - et al.
Covered versus uncovered Wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis
Clin Gastroenterol Hepatol
(2006) - et al.
Features of malignant biliary obstruction affecting the patency of metallic stents: a multicenter study
Gastrointest Endosc
(2002) - et al.
Localized paclitaxel delivery
Int J Pharm
(1999) - et al.
Efficacy and complications of covered Wallstents in malignant distal biliary obstruction
Gastrointest Endosc
(2005)